BABY CONTROL COSYCOT INFANT WARMER
Report
- Report Number
- 9611451-2022-00968
- Event Type
- Malfunction
- Date Received
- October 24, 2022
- Report Date
- October 10, 2022
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- PMA / PMN Number
- K971461
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(4). THE COMPLAINT IW980 WALL MOUNT INFANT WARMER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). CORRECTED DATA: SECTION H4. DEVICE MANUFACTURE DATE: 14-DEC-2011 METHOD: THE COMPLAINT IW980 WALL MOUNT INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN THE UNITED KINGDOM WHERE IT WAS EVALUATED BY A TRAINED F&P TECHNICIAN. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. RESULTS: DURING TESTING IT WAS FOUND THAT THE UNIT'S POWER FAIL ALARM DID NOT FUNCTION WHEN THE UNIT WAS DISCONNECTED FROM POWER. CONCLUSION: THE CAUSE WAS IDENTIFIED TO BE THE FAILURE OF A CAPACITOR ON THE PCB BOARD. PART OF FISHER & PAYKEL HEALTHCARE'S QUALITY CONTROL PROCESS INVOLVES TESTING THE POWER FAILURE ALARM OF EVERY WARMER ON THE PRODUCTION LINE FOR FUNCTIONALITY PRIOR TO DISTRIBUTION. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS INCLUDING THE POWER FAIL ALARM AT LEAST ONCE A YEAR. INCLUDED IN THE WARMER'S MAINTENANCE CHECKLIST IS A TEST OF THE SUPER CAPACITOR TO ENSURE IT IS OPERATING WITHIN SPECIFICATIONS.
(B)(4). CORRECTED DATA: SECTION D4. SERIAL #: (B)(6); LOT #: 070126. SECTION H4. DEVICE MANUFACTURE DATE: 26-JAN-2007. METHOD: THE COMPLAINT IW980 WALL MOUNT INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN THE UNITED KINGDOM WHERE IT WAS EVALUATED BY A TRAINED F&P TECHNICIAN. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. RESULTS: DURING TESTING IT WAS FOUND THAT THE UNIT'S POWER FAIL ALARM DID NOT FUNCTION WHEN THE UNIT WAS DISCONNECTED FROM POWER. CONCLUSION: THE CAUSE WAS IDENTIFIED TO BE THE FAILURE OF A CAPACITOR ON THE PCB BOARD. PART OF FISHER & PAYKEL HEALTHCARE'S QUALITY CONTROL PROCESS INVOLVES TESTING THE POWER FAILURE ALARM OF EVERY WARMER ON THE PRODUCTION LINE FOR FUNCTIONALITY PRIOR TO DISTRIBUTION. THE DEVICE TECHNICAL/SERVICE MANUAL CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE AND FUNCTIONAL CHECKS INCLUDING THE POWER FAIL ALARM AT LEAST ONCE A YEAR. INCLUDED IN THE WARMER'S MAINTENANCE CHECKLIST IS A TEST OF THE SUPER CAPACITOR TO ENSURE IT IS OPERATING WITHIN SPECIFICATIONS.
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE POWER FAIL ALARM OF A IW980 WALL MOUNT INFANT WARMER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE POWER FAIL ALARM OF A IW980 WALL MOUNT INFANT WARMER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE POWER FAIL ALARM OF A IW980 WALL MOUNT INFANT WARMER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370559 | BABY CONTROL COSYCOT INFANT WARMER | FMT | FMT | FISHER & PAYKEL HEALTHCARE LTD | IW980 | 070126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |